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Heterozygous Familial Hypercholesterolemia (HeFH)

4
Pipeline Programs
3
Companies
3
Clinical Trials
1 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
2
2
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

3 companies ranked by most advanced pipeline stage

MSD
MSDIreland - Ballydine
2 programs
1
1
AnacetrapibPhase 31 trial
Enlicitide DecanoatePhase 2/31 trial
Active Trials
NCT07058077Recruiting153Est. Jan 2037
NCT01824238Completed68Est. May 2014
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
2 programs
1
1
AnacetrapibPhase 3
Enlicitide DecanoatePhase 2/3
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
QLC7401 InjectionPHASE_31 trial
Active Trials
NCT07450378Not Yet Recruiting120Est. Jul 2028

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Qilu PharmaceuticalQLC7401 Injection
MSDAnacetrapib
MSDEnlicitide Decanoate

Clinical Trials (3)

Total enrollment: 341 patients across 3 trials

NCT07450378Qilu PharmaceuticalQLC7401 Injection

QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Start: May 2026Est. completion: Jul 2028120 patients
Phase 3Not Yet Recruiting
NCT01824238MSDAnacetrapib

A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Heterozygous Familial Hypercholesterolemia (MK-0859-050)

Start: May 2013Est. completion: May 201468 patients
Phase 3Completed
NCT07058077MSDEnlicitide Decanoate

A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)

Start: Aug 2025Est. completion: Jan 2037153 patients
Phase 2/3Recruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 341 patients
3 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.